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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00467571
Other study ID # ID11-48-20
Secondary ID
Status Completed
Phase Phase 4
First received April 27, 2007
Last updated May 1, 2013
Start date March 2006
Est. completion date December 2008

Study information

Verified date September 2008
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

Previous studies suggest that chronic idiopathic thrombocytopenic purpura is associated with Helicobacter pylori infection. The objective is to study the effect of Helicobacter pylori eradication on platelet count.


Description:

Children with chronic idiopathic thrombocytopenic purpura who have Helicobacter pylori infection are enrolled. Helicobacter pylori infection is diagnosed by urea breath test. Patients who have Helicobacter pylori infection will be randomized into 2 groups: control and treatment groups. The treatment group will receive 2 antibiotics and proton-pump inhibitors for 14 days for eradication of infection. Repeated urea breath test at week 6-8 after treatment. Blood tests for platelet count will be performed every month for 6 months in both groups. Platelet count at 6 months in both group will be compared.Blood for platelet antibody will be performed at 3 and 6 months. Control group will receive treatment for Helicobacter pylori at the end of the study.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date December 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria:

- Children who was diagnosed as chronic ITP, defined by platelets below 100,000/uL for more than 6 months without identified causes.

- 13C-urea breath test (UBT) was performed for diagnosis of Helicobacter pylori infection.

Exclusion Criteria:

- Patients who had a previous treatment for H. pylori infection.

- Patients require prednisolone more than 0.5 mg/kg/day

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
lansoprazole, clarithromycin, amoxycillin
lansoprazole (15, 30 mg) 1 tab twice daily, clarithromycin 7.5 mg/kg twice daily, amoxycillin 25 mg/kg twice daily; rout: orally; duration 14 days

Locations

Country Name City State
Thailand Faculty of Medicine, Ramathibodi Hospital, Mahidol University Bangkok

Sponsors (2)

Lead Sponsor Collaborator
Mahidol University Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary platelet count 6 months No
Secondary platelet antibody after treatment of Helicobacter pylori infection, compared with control group (no treatment of Helicobacter pylori) 6 months No
Secondary platelet count 6 months No
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